- Merck & Co. (North Wales, PA)
- …the Research & Development organization at our company. Position Description/Summary The Senior Specialist , Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- The CMC Regulatory Affairs Specialist ...with highest quality. * Participates in CMC project team meetings and provides current regulatory ... with regulatory requirements, as necessary. * Tracks and/or completes CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs. * Provides CMC… more
- ConvaTec (Lexington, MA)
- …working relationships within RA group as well as internal/external customers. ** Regulatory Affairs Specialist work includes:** Direct submission development of ... to expedite approval of pending registration and answer questions;** Serve as regulatory liaison on project team throughout the product lifecycle;** Participate… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …and clinicians in hematology, immunology, neurology, and transfusion medicine. The **Sr. Specialist for Regulatory Affair** **s** is responsible for ... including submission, operational and compliance for US-licensed products and additional project /s assigned. Responsibilities include: + As the US Product Owner… more
- Bausch + Lomb (Bridgewater, NJ)
- …advancement of eye health in the future. **Objectives/Purpose of Job:** + The Regulatory Affairs Senior Specialist handles US regulatory development aspects ... for Over-the-Counter (OTC) or cosmetic products, as assigned. + Provides Regulatory guidance to support marketed OTC monograph/NDA or cosmetic products. + Manages… more
- Merck (Boston, MA)
- …partner organizations such as Clinical Sciences and Study Management (CSSM), Regulatory , Chemistry, Manufacturing and Controls ( CMC ), Pharmaceutical Sciences, ... teams and the operational/executional arms within the business. Clinical Supplies Project Managers (CSPMs) are responsible for the translation of global clinical… more
- Merck (North Wales, PA)
- …the Research & Development organization at our company. **Position Description/Summary** The Senior Specialist , Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their regulatory ... as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …across the company, including Manufacturing, Process Sciences (PS), Quality Control (QC), CMC Regulatory Sciences, and Quality Assurance (QA) to provide ... Regeneron is currently looking for a Materials Sciences Specialist for Extractables and Leachables (E&L) in the...projects and deliverables to support pre and post marketing regulatory commitment deadlines, and development of new projects and… more
- Bausch Health (Bridgewater, NJ)
- …of improving people's lives with our health care products. The Quality Specialist provides support for the business' product development portfolio and ensures ... to Quality-by-Design principles as well as compliance with relevant regulatory requirements and corporate standards. Experience: + Partner with cross-functional… more
- Insight Global (Rahway, NJ)
- …largest pharmaceutical clients is looking for someone to join their Global Regulatory Affairs organization and Regulatory Information Management team to support ... change management initiatives, including managing a suite of documentation that supports regulatory processes and transforming this documentation with the use of the… more
- Merck (Elkton, VA)
- …Company, including Technical Operations, Operations, Quality, commercialization, process development, Regulatory - CMC , Supply Chain, and Value Chain. **Key ... achieve Vaccine strategic goals. Participate as a technical expert and/or as a project leader in various projects. + Ensure process robustness for the Vaccinel… more
- Actalent (Foster City, CA)
- …variety of activities to ensure compliance with applicable quality objectives and regulatory requirements * Serves as Analytical Operation Lead for clinical and ... and finished products. * Reviews and audits method validation related data in CMC sections of NDA / global filings. * Responsible for maintaining current knowledge… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... in accordance with Rush policies and procedures. **Responsibilities:** * Appropriately manage project billing by ensuring costs are correctly billed and invoices are… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... timely manner. * Review clinical trial protocols and related regulatory documents to prepare a billing plan for all...medical procedures and services required in a clinical research project . * Review clinical research protocols and determine which… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include: Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents in order to prepare a billing plan for all medical procedures… more
- RTX Corporation (Forest, MS)
- …United States of America Location: MS301: 19859 Highway 80, Forest 19859 Highway 80 CMC Forest, Forest, MS, 39074 USA Position Role Type: Onsite At Raytheon, the ... an Information System Security Officer (ISSO) known as a Principal Specialist within the organization. The ISSO will support classified computing environments… more
